EVALUATION OF THE BINDING PROPERTIES OF ENZYME – HYDROLYZED CASSAVA STARCH IN CHLOROQUINE PHOSPHATE TABLET FORMULATIONS


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TABLE OF CONTENTS

Tittle Page
Abstract
Table of Contents
Abbreviations, Definations, Glossaries and symbols
Keys

CHAPTER ONE
1.0       INTRODUCTION
1.1       Pharmaceutical Tablets
1.2       Stability of Solid Dosage Forms
1.3       Drug release from solid dosage form
1.4       Tablet Manufacturing
1.5       Dosage compliance
1.6       Mechanical strength of tablets
1.6.1    Attributes of an ideal tablet
1.6.2    Types of tablet
1.6.3    Oral tablets for ingestion
1.6.4    Tablets used in oral cavity
1.6.5    Tablets administered by other routes
1.6.6    Advantages of tablets
1.6.7    Disadvantages of tablets
1.7       Pharmaceutical Excipients
1.7.1    Disintegrating agents
1.7.2    Glidant, antiadherent lubricant
1.7.3    Colouring and flavouring agents
1.7.4    Fillers/Diluents
1.7.5    Pharmaceutical binders
1.8       Volume reduction of pharmaceutical powders
1.9       Bonding in tablet
1.10     The process of compaction
1.11     Factors affecting drug release from tablets
1.11.1  Wetting
1.11.2  Water penetration
1.11.3  Disintegration
1.12     Dissolution
1.12.1  Interfacial reaction
1.12.2  Diffusion through the boundary layer
1.13     Enzyme Hydrolysis
1.14     Enzyme - hydrolyzed Starch
1.15     Statement of research problem
1.16     Justification for the study
1.17     Research Hypothesis
1.18     Aim
1.19     Objective
1.20     Scope of Work

CHAPTER TWO
2.0       LITERATURE REVIEW
2.1       Starch
2.2       Morphology of starch
2.3       Gelatinization
2.4       Varieties and properties of starch granules
2.5       Starch modification
2.5.1    Acid hydrolysis of starch
2.5.2    Cross- linking
2.5.3    Stabilization
2.5.4    Enzyme hydrolysis
2.5.5    Pregelatinization
2.5.6    Annealing
2.6       Recent studies on modified starches
2.7       Chloroquine phosphate
2.8       Granulation
2.9       Wet granulation
2.9.1    Important Steps involved in the wet granulation
2.9.2    Limitation of wet granulation
2.10     Special wet granulation techniques
2.10.1  High shear mixture granulation
2.10.1.1           Advantages
2.10.2  Fluid bed granulation
2.10.3  Extrusion and spheronization
2.10.3.1 Advantages
2.10.4  Spray drying granulation
2.10.4.1 Advantages
2.11     Dry granulation
2.11.1  Advantages
2.11.2  Disadvantages
2.12     Steps in Dry granulation
2.13     Commonly used dry granulation processes
2.13.1  Slugging process
2.13.1.1           Factors which determine how well a material may slug
2.13.2  Roller compaction
2.14     Dry granulation
2.15     Recent Advances in granulation technique
2.16.    Direct compression
2.16.1  Steps in direct compression
2.16.2  Direct compression Excipients
2.17     Merits of direct compression
2.18     Demerits of direct compression
2.18.1  Excipients Related demerits
2.18.2  Process Related demerits
2.19     Essential Excipients for direct compression
2.20     Tablet compression
2.21     Compressional characteristics of granules
2.22     Tablet properties
2.23     Tabletting machines
2.24     Modifications of tableting machines
2.24.1  Compaction simulator

CHAPTER THREE
3.0       MATERIALS AND METHODS
3.1       Materials
3.2       Methods
3.2.1    Collection and identification of cassava tuber
3.2.1.1 Extraction of cassava starch
3.2.1.2 Preparation of Enzyme- hydrolyzed starch (EHS)
3.3       Physicochemical tests on the starch
3.3.1    Organoleptic properties
3.3.2    Test for starch
3.3.3    Ash Content
3.3.4    PH determination
3.3.5    Solubility
3.3.6    Microscopy
3.3.7    Percentage moisture loss
3.3.8    Bulk and tapped densities
3.3.9    Moisture sorption capacity
3.3.10  Particle density
3.3.11  Powder porosity
3.3.12  Swelling power
3.3.13  Hydration capacity
3.4       Formulation Studies
3.4.1    Preparation of granules
3.4.2    Physico-chemical tests on granules
3.4.3    Bulk and tapped densities
3.4.4    Particle size analysis
3.4.5    Determination of flow rate
3.4.6    Determination of angle of repose
3.5       Tablet Production
3.5.1    Tablet Properties (Quality Control test)
3.5.1.1 Uniformity of weight
3.5.1.2 Diameter measurement
3.5.1.3 Thickness and porosity
3.5.1.4 Crushing strength
3.5.1.5 Friability test
3.5.1.6 Density of tablets
3.5.1.7 Disintegration Time studies
3.5.1.8 Dissolution studies
3.6       Tablet Tensile Strength

CHAPTER FOUR
4.0       RESULTS
4.1       Organoleptic Tests
4.2       Microscopy
4.3       Particle size analysis
4.4       Physical properties of chloroquine granules
4.5       Effect of various Binder Concentrations on granules
4.7       Evaluation of tablets properties produced by wet Granulation
4.8       Dissolution profile
4.9       Evaluation of tablet properties by direct compression

CHAPTER FIVE
5.0       DISCUSSION
5.1       Preliminary investigation of starch
5.2       Physicochemical properties of Granules
5.3       Evaluation of CQ tablets by wet granulation method
5.4       Evaluation of CQ tablets by direct compression
5.5       Mechanical properties of CQ phosphate formulation at various binding concentrations

CHAPTER SIX
6.0       SUMMARY AND CONCLUSION
6.1       SUMMARY
6.2       CONCLUSION
6.3       RECOMMENDATIONS
REFERENCES
APPENDICES


ABSTRACT

Starch is a major carbohydrate, easily extractable from various sources like cassava, maize, potato etc which find wide application in various food and Pharmaceutical industries. There has been a lot of attempt to modify this highly flexible polymer with the aim of extending and enhancing its applications.

Native cassava starch (NCS) was extracted from the tubers of freshly harvested cassava. Enzyme- hydrolysed starch (EHS) was produced from Native cassava starch (NCS) using enzymatic hydrolysis method with α – amylase as the enzyme.

The physicochemical characterization for NCS and EHS was conducted using standard methods, such as flow rate, angle of repose, mean particle size, moisture content, Carr‟s index, Hausner‟s ratio, ash content, swelling power, pH, bulk and tapped densities.

Chloroquine tablets were formulated by wet granulation method and direct compression using EHS, MCC, MS and NCS as binders at different concentrations of 2.5, 5, 7.5 and 10 %w/v. The tablet characteristics were evaluated and compared with that of MCC and maize starch.

The mechanical properties using crushing strength and friability for NCS and EHS were carried out. The crushing strength increased with increase in binder concentration while friability decreased. The disintegration time also increased with increase in binder concentration. The disintegration and dissolution profile of the tablets were studied and these were much faster for EHS tablets when compared to that of PVP.

Using the direct compression method, crushing strength was found to increase with increase in binary mixture of MCC and the friability increases with increase in the proportion of EHS. The Disintegration time was above 60 min., the tablet continued to swell, absorbing more water without disintegrating for the period of the study.


The study found out that EHS is comparable to standard starches and can be used as a binder in wet granulation and direct compression method in Pharmaceutical industries to produce the tablets.




CHAPTER ONE

INTRODUCTION

1.1              Pharmaceutical Tablets

Solid formulations are the preparations of pharmaceutical products in their dried, powdered or solid state and these include powders, capsules, granules and tablets. Dosage forms are designed to provide the drug in a suitable form for absorption from each selected route of administration.

Oral administration of drugs is the most frequently used route, simple, convenient and safe. Over 80 % of the drugs formulated to produce systemic effects in the world are produced as oral dosage forms (Rudnic and Kottke, 1999). Oral tablet was introduced as early as 1843 by an Englishman Brockedon, who invented the first hand-operated device for compressed pills. These pills, powders, capsules which were made by hand continued to be in vogue for a long time before the development of the modern pharmaceutical industry and effective production methods.

Tablets are solid pharmaceutical dosage forms containing medicinal drug substances with or without suitable diluents and compressed by means of a tableting machine or by moulding methods (Remington. 2005).

Tablets can also be defined as solid preparations each containing a single dose of one or more active substances and usually obtained by compressing uniform volumes of particles (European Pharmacopoeia, 2002). The most popular oral dosage forms are tablets, capsules, suspensions, solutions and emulsions, tablets are prepared by compaction and they contain drugs and formulation additives which are included for specific functions (Aulton, 2007)......


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